scholarly journals Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Florfenicol and Flunixin Meglumine Combination in an Injectable Solution

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Nidal Batrawi ◽  
Hani Naseef ◽  
Fuad Al-Rimawi
Keyword(s):  
Simultaneous Determination ◽  
Reversed Phase ◽  
Hplc Method ◽  
Base Hydrolysis ◽  
Water Mixture ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Flunixin Meglumine ◽  
Development And Validation

The combination of the powerful antimicrobial agent florfenicol and the nonsteroidal anti-inflammatory flunixin meglumine is used for the treatment of bovine respiratory disease (BRD) and control of BRD-associated pyrexia, in beef and nonlactating dairy cattle. This study describes the development and validation of an HPLC-UV method for the simultaneous determination of florfenicol and flunixin, in an injectable preparation with a mixture of excipients. The proposed RP-HPLC method was developed by a reversed phase- (RP-) C18e (250 mm × 4.6 mm, 5 μm) column at room temperature, with an isocratic mobile phase of acetonitrile and water mixture, and pH was adjusted to 2.8 using diluted phosphoric acid, a flow rate of 1.0 mL/min, and ultraviolet detection at 268 nm. The stability-indicating method was developed by exposing the drugs to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation; the obtained degraded products were successfully separated from the APIs. This method was validated in accordance with FDA and ICH guidelines and showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria.

Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide

2019 ◽  
Vol 12 (5) ◽  
pp. 4635-4645
Author(s):  
Pankaj Padmakar Nerkar ◽  
Sameer Ansari ◽  
Shailesh Chalikwar
Keyword(s):  
Ammonium Acetate ◽  
Correlation Coefficients ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to        10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (acid, base) oxidation, photolysis and thermal degradation and the stressed samples were analysed by the developed method. The method was validated for the precision, accuracy, linearity and robustness. The developed stability indicating method for enzalutamide was validated as per ICH guidelines.

Development and Validation of Stability-indicating Reverse Phase HPLC Assay for Tramadol in Bulk and Tablet Formulations

2019 ◽  
Vol 12 (3) ◽  
pp. 4544-4552
Author(s):  
Pankaj Padmakar Nerkar ◽  
Vaishali Badjuar ◽  
Pradyum Ige ◽  
Hitendra Mahajan ◽  
Sameer Ansari
Keyword(s):  
Orthophosphoric Acid ◽  
Correlation Coefficients ◽  
Reversed Phase ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Tablet Formulations ◽  
Development And Validation

This manuscript describes the development and validation of a simple, isocratic, and accurate reversed-phase HPLC method for the assay of tramadol in bulk powder form and tablet formulations. The chromato-graphic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5μm) column using acetonitrile: methanol: phosphate buffer pH 3.4 adjusted with orthophosphoric acid: (20:10:70, v/v) as a mobile phase, at a flow rate of 1 mL/min and detection at 271 nm. The linear range for tramadol were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.999. The retention time was found to be 4.47 min for tramadol that was subjected to stress conditions, such as hydrolysis, oxidation, photolysis and thermal degradation, and the stressed samples were analyzed using the above methodology. The method was validated for the precision, accuracy, linearity and robustness. The developed stability-indicating method for tramadol was validated as per ICH guidelines.

scholarly journals Development and Validation of an HPLC Stability-Indicating Method for Identification and Assay of Elemental Iron(II) in Pharmaceutical Drug Products Using Reversed-Phase HPLC

2011 ◽  
Vol 94 (4) ◽  
pp. 1233-1239
Author(s):  
Neil C Dias ◽  
Abu M Rustum
Keyword(s):  
Ferrous Sulfate ◽  
Methanesulfonic Acid ◽  
Reversed Phase ◽  
Hplc Method ◽  
Elemental Iron ◽  
Stability Indicating ◽  
Drug Products ◽  
Stability Indicating Method ◽  
The Matrix ◽  
Development And Validation

Abstract Ferrous sulfate tablets are a supplementary iron source for people who suffer from iron defciency anemia. A simple, fast, and QCfriendly HPLC method was developed and validated to determine elemental iron in ferrous sulfate drug products. A TSK-GEL Super octadecylsilyl column (50 × 4.6 mm id, 2 µm particle size) with a mobile phase consisting of 0.06 M methanesulfonic acid in water–acetonitrile (40 + 60, v/v) and UV detection at 282 nm were used for this method. Separation of the elemental iron peak from the matrix was achieved within 5 min. This method was successfully validated according to International Conference on Harmonization guidelines, and shown to be stability-indicating for the shelf-life samples of ferrous sulfate tablets, as well as selective for the analyte of interest.

Sign in / Sign up

Export Citation Format

Share Document